FDA slow walking a long-awaited abortion pill safety study

Charles Gorrivan, Riley Griffin and Rachel Cohrs Zhang, Bloomberg News on Dec 8, 2025

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The Food and Drug Administration has delayed a promised review of safety data for the abortion drug mifepristone at Commissioner Marty Makary’s request to put it off until after the midterm elections, according to people familiar with the matter.

Makary and Health and Human Services Secretary Robert F. Kennedy Jr. have told lawmakers and state attorneys general for months that they are actively conducting a review of mifepristone. But behind the scenes, Makary has told agency officials to delay the safety review, people familiar with the discussions said.

“Assertions that the FDA is slow walking this review for political purposes are baseless,” HHS spokesperson Andrew Nixon said. “FDA’s comprehensive scientific reviews take the time necessary to get the science right.”

Pushing the closely watched abortion pill study beyond next year’s midterms has the potential to help minimize the role of abortion in the upcoming elections, in which some Republicans are facing tough battles to hold onto their seats. Abortion restrictions popular with the right-wing base don’t necessarily poll well with all voters. A 2024 Pew survey found majorities of moderate or liberal Republicans say abortion should be legal in all or most cases.

Still, a group of Republican lawmakers have been pressing forward with asking health agencies to conduct an abortion pill safety study — despite the fact that many leading medical organizations have long deemed the drug safe. Their goal is to roll back Biden-era policies that made the abortion pill available without an in-person doctor’s visit.

Kennedy and Makary have been publicly saying the study is moving forward. In a Sept. 19 letter to Republican attorneys general, they said “HHS — through the FDA — is conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug.”

A month later, after the agency approved another generic version of the abortion pill, 17 GOP senators pressed Makary for details about the status of that safety review in a letter dated Oct. 16, expressing concern the agency wasn’t working quickly enough.

At-home abortions

The easing of access to the abortion pill came after a long battle in which the reproductive rights community pointed to a large body of evidence shows that the pill is safe enough for women to take at home. A 2013 paper reviewing abortion data for 45,000 women showed just 0.3% of patients who took the pill ended up hospitalized. The study’s authors concluded that abortion by pill is “highly effective and safe.”

Studies the FDA cites in its prescribing information puts the rate of serious side effects at less than 0.5%. The drug is used in nearly two-thirds of U.S. abortions and for miscarriage management, according to the American Civil Liberties Union, which estimates that roughly 7.5 million Americans have taken the drug since the FDA first approved it in 2000.

Abortion has been a flash point in state elections since the fall of Roe v. Wade in 2022, with many ballot measures moving to protect access. The issue has often transcended partisan lines: In 2024, millions of voters cast ballots for both Donald Trump and state-level abortion protections. Now, as the 2026 midterm elections approach and states consider new initiatives, Republicans are bracing for renewed scrutiny — and the question remains whether threatened abortion access will shape how voters judge candidates.

Anti-abortion activists have pushed for Makary to roll back the looser, Biden-era rules around mifepristone’s use. A conservative think tank released an opaque analysis of insurance claims in April claiming a higher rate of adverse events for the drug than larger studies had found. Senator Josh Hawley, a Republican from Missouri, cited the data in a May hearing with Kennedy as he pressed the secretary to review safety data related to the drug.

Makary’s agency, which is charged with making sure that food and drugs Americans take are safe, has been consumed by internal turmoil after several high-profile departures in recent weeks. The division that would lead the safety review for mifepristone has had five directors since the beginning of the year.

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